IMI2: why, what, how?

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1 IMI2: why, what, how? The Right prevention and treatment, to the right patient, at the right time Isabelle Thizon-de Gaulle VP, Strategic initiatives & Scientific relations Sanofi R&D

2 Innovative Medicines Initiative: EU Partnership for Health ,28 Billion Public/Private = EU + Pharma + Other industries

3 IMI projects to date

4 4

5

6 IMI delivers on Innovation and Health Established robust validated models for Alzheimer, Diabetes, Schizophrenia, Asthma Developed clinically relevant biomarkers for Alzheimer, Diabetes, Schizophrenia, Asthma Established Robust tools for drug safety prediction, prevention and monitoring Establishment and regulatory submission of key standards and tools for drug development in infectious diseases, COPD, diabetes Improved clinical trial design and process in schizophrenia, pain, autism Co-funding by EU of antibiotics development Projects launched and planned on use of real life data and alignment of regulators and payers data requirement Many of the above pave the way for new regulatory pathways aligned with science and technology development and creating pull incentives Uptake by Regulators has started (guidance, biomarkers)

7 Evolution of IMI the road to IMI2 Make Drug R&D processes in Europe more efficient and effective and enhance Europe s competitiveness in the Pharma sector Idea generation Basic research and non-clinical testing Human testing Regulatory Approval HTA and Pharmacovigilance Daily Medical practice Primary focus of early IMI calls 2007 SRA SRA Strategic Research Agenda Shift to also addressing challenges in in society and healthcare 2011 SRA 7 IMI 2 includes real life medical practice 2013 SRA

8 Pre-Clinical Research Closed & Open Innovation EMA Filing EMA Approval for Sale HTA Approval Negotiation for Reimbursement 27 member States Current EU pathways are expensive and slow in getting new therapies to patients New therapies Drug Discovery 5,000 10,000 Compounds Pre Clinical Testing 250 Compounds Clinical Trials Phase 1 Phase 2 Phase 3 5 Therapies 1 Therapy don t reach patients until here Regulatory Review The patient s perspective General response rates to modern medicine PhV Monitoring Number of Patients/Subjects Years 6 7 Years 2 5 Years Total Cost: $2 - $4 Billion USD Science offers new opportunities Sources: Drug Discovery and Development: Understanding the R&D Process, CBO, Research and Development in the Pharmaceutical Industry, 2006; Forbes, Matthew Herper, The Truly Staggering Cost Of Inventing New Drugs, February 10, R&D model revamping 10 26/05/14 Molecular diagnosis based on biological knowledge We treat a population. Some respond and some don t We treat a targeted population They all respond 8 22/05/14

9 IMI2 vision towards integrated healthcare solutions Addressing healthcare priorities identified by the WHO 2013 report Strategic Research Agenda aimed at progressing the vision of stratified medicines: prevention, treatment and health management Entire product cycle from discovery, through development to healthcare delivery and access models Collaboration across sectors to harness all knowledge and technologies which can contribute to IMI2 vision - diagnostics, imaging, IT, medical devices,

10 IMI2 Strategic Research Agenda Priorities: WHO report on priority medicines Input: 70+ scientific, research, patient, regulatory organisations Endorsed by the IMI Scientific Committee

11 Therapeutic areas covered by the IMI2 SRA Therapeutic Areas in IMI2 SRA (no priority order)

12

13 IMI2 scientific programme: First five big themes Therapeutic Areas and Cross-cutting Themes Differentiating Enablers for all themes Neuro-degeneration Successfully prevent and treat dementia and other neurodegenerative diseases Prevention and treatment of immunemediated disease Advance immunological understanding to deliver new medicines and new and better vaccines Metabolic disorders Tackle all phases of disease and its complications, including prevention and early interception Infection control Address big societal problem related to multidrug resistance and develop new and better vaccines Translational Safety Development of new human biology platform to predict toxicity and safety during early drug development Towards early and effective patient access to innovative prevention and treatment solutions (MAPPs): Target validation based on human biology Stratified medicine, precision medicine Innovation in clinical trials Data generation and interpretation (knowledge management) Prevention, disease interception, patient adherence (incl. societal acceptance of vaccines) Effect on medical practice and outcomes (health/disease management) Regulatory framework (including pharmacovigilance) Patient access

14 First five big themes Prioritisation/selection criteria Field of unmet need Patient-centric approach Science ready to make a big change over the next decade Added value of PPP to make a difference Synergies with other global initiatives While keeping focus on prioritised questions, there is sufficient room for other projects within the SRA e.g. Oncology; Rare/Orphan Diseases; Psychiatric Diseases; Respiratory Diseases

15 How to submit a proposal for a project or a scientific question? 15

16 Conclusions Focused: stratified medicines and healthcare priorities Healthcare solutions: prevention and treatment End-to-end: R&D, regulatory, access/healthcare practice Multi-sector: within and beyond life sciences there is room for win-win collaborations Submit your ideas:

17 EFPIA Brussels Office Leopold Plaza Building Rue du Trône 108 B-1050 Brussels - Belgium Tel: +32 (0)

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